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Study aim:
Determine the efficacy and safety of intradermal tranexamic acid mesotherapy compared with placebo for the improvement of periorbital wrinkles
Design:
A randomized, double-blind, placebo-controlled, parallel-group (split-face design), phase 2 clinical trial on 20 patients (40 periorbital sides). For randomization Sealed Envelope System was used.
Settings and conduct:
This study is conducted at the Dermatology Clinic of Shahid Faghihi Hospital, Shiraz University of Medical SciencesPatients receive 4 weekly periocular injections of tranexamic acid on one side and placebo contralaterally. It is double-blind; patients, clinical evaluators, and image analysts are masked using third-party identically coded syringes
Participants/Inclusion and exclusion criteria:
Patients aged 30–60 years with periorbital wrinkles (WSRS≥2). Inclusion criteria: written consent; no cosmetic procedures in past 3 months or eye creams in past week. Exclusion criteria: pregnancy; lactation; coagulopathies; history of thromboembolism;
Intervention groups:
Intervention Group: Intradermal micro-injections of tranexamic acid (100 mg/mL) into one periorbital side at 0.1 mL per puncture point spaced 1 cm apart (total volume 1.0–1.5 mL per session) using a 30G needle, administered weekly for 4.
Control Group: Intradermal micro-injections of normal saline into the contralateral periorbital side with identical injection technique, spacing, volume (0.1 mL per puncture; total 1.0–1.5 mL per session), and 30G needle, administered weekly for 4 consecutive sessions.
Main outcome variables:
Change in periorbital wrinkle volume measured by VisioFace at 1-month post-treatment; change in clinical wrinkle severity based on WSRS; change in wrinkle area and depth via VisioFace analysis; patient satisfaction score using a 5-point Likert scale; incidence of local and systemic adverse events